Pharmacovigilance is the science of collecting, monitoring, researching, assessing, and evaluating information from healthcare providers and patients on the adverse effects of medications with a view towards identifying hazards associated with the medications and preventing harm to patients.
A typical health care system includes a variety of participants, including doctors, hospitals, insurance carriers, and patients, among others. These participants frequently rely on each other for the information necessary to perform their respective roles because individual care is delivered and paid for in numerous locations by individuals and organizations that are typically unrelated. As a result, a plethora of health care information storage and retrieval systems are required to support the heavy flow of information between these participants related to patient care. Critical patient data is stored across many different locations using legacy mainframe and client-server systems that may be incompatible and/or may store information in non-standardized formats. To ensure proper patient diagnosis and treatment, health care providers often request patient information by phone or fax from hospitals, laboratories, or other providers. Therefore, disparate systems and information delivery procedures maintained by a number of independent health care system constituents lead to gaps in timely delivery of critical information and compromise the overall quality of clinical care. Since a typical health care practice is concentrated within a given specialty, an average patient may be using services of a number of different specialists, each potentially having only a partial view of the patient's medical status.
Moreover, pharmacovigilance is facing increased pressure from regulators and academics who are mining real-world databases for safety signals. Some factors affecting the pharmacovigilance landscape include: an increasing use of real-world data by regulators; heightened expectations of manufacturers from the FDA (Food and Drug Administration), public, and academics/investigators; externalization of safety data (e.g., EMR (electronic medical records); and emergence of pharmacovigilance as an applied science.
There are certain limitations to the way in which pharmacovigilance is currently being implemented. Firstly, pharmacovigilance, or drug surveillance, is typically done by “ad hoc” reporting, where a physician independently identifies patients that have a problem with a certain drug and report this singular instance to the FDA. The FDA then accumulates this information and communicates with pharmaceutical manufacturers. This process is inefficient and ineffective. To overcome some of the drawbacks of the ad hoc approach, the FDA has implemented the “Sentinel” and “Mini Sentinel” initiatives. However, these initiatives look at retrospective and/or historical data to perform drug surveillance.
Accordingly, there remains a need in the art for a system and method for pharmacovigilance that overcomes the drawbacks and limitations of current approaches.